Search 7 medical device jobs

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Latest Jobs

Jun 06, 2022  
$70,000 - $90,000 yearly
BiVACOR is a young start-up eager to advance our products from laboratory to clinic. We are committed to establishing Quality Assurance practices that are supportive of our ongoing R&D activities. Now seeking a motivated experienced Quality Engineer team member to contribute to this dynamic project in our Huntington Beach Office CA. The Quality Engineer (QE) will support preparation and review of documentation and inspection required for manufacture and test of the Total Artificial Heart (TAH) system and will work with the team to assist in implementing a QM system in accordance with ISO 13485 and 21 CFR 820. The QE will work on daily Quality Assurance (QA) activities by supporting creation and review of work instructions, inspection instructions, test protocols, and process Design Change Orders (DCO). The QE will also support inspection activities both internal at BiVCOR and its suppliers. The QE will work closely with the internal engineering staff to the support...
BiVACOR Inc Full time
Jun 06, 2022  
$110,000 - $130,000 yearly
BiVACOR is a young start-up eager to advance our products from laboratory to clinic. We are committed to establishing Quality Assurance practices that are supportive of our ongoing R&D activities. Now seeking a motivated team member to contribute to this dynamic project in our Cerritos Engineering Office. If you have strong organizational, leadership, and interpersonal skills then you should apply to join our energetic and diverse team. The Quality Assurance Manager will work to develop and implement a quality management system in accordance with ISO 13485, 21 CFR 820, and MDR 2017/745. Strong preference will be given to candidates with hands-on, professional experience working with FDA Class III Medical Devices.   RESPONSIBILITIES Lead development and implementation of in-house QMS Lead planning and implementing good manufacturing practice (GMP) and good laboratory practice (GLP) systems Co-leads (with R&D) in implementing Design Control: Conduct risk...
BiVACOR Inc Full time
May 26, 2022  
$90,000 - $120,000 yearly
The Manager of Operations/Quality Affairs, will be responsible for providing operational and quality leadership both strategically and in day-to-day activities. This individual will have sole responsibility for regulatory compliance related activities such as supplier management, change controls, deviations and general QMS maintenance. This individual will also ensure that the QMS and all business activities are in compliance with applicable US and international regulations and will be responsible for planning activities to ensure continued compliance.  This role requires the ability to develop and maintain cooperative working relationships with team members to effectively ensure compliance and timeliness of both (vendor) manufacturing and regulatory activities.   Responsibilities Manage the QMS to include CAPAs, Post-Market Surveillance, Training, Document and Change Control and Record Management. Manage audits (supplier audits as well as third-party, notified body or...
Zetagen Therapeutics Remote (Dallas, TX, USA) Full time
May 13, 2022  
Sprig Oral Health Technologies, Inc. Join our Amazing Team! Sprig Oral Health Technologies, Inc is an innovative and evolving medical device company that is making a positive difference in the field of pediatric dentistry.  Apply online at www.sprigusa.com and go to “careers” link at the bottom of the website. We Offer: Friendly and fun company culture!    Full benefit package including Medical, Dental, Vision, and Life Insurance  Competitive salary offered that aligns with the market for this type of position EAP (Employee Assistance Plan offering FREE mental health services) 2 weeks paid vacation per year 401(k) with company match 9 Paid Holidays Wellness program Tuition Reimbursement, Professional Development and Career Advancement Opportunities Located in Loomis, CA, we offer convenient and free, onsite parking.  Our jobsite is also within easy walking distance to many conveniences including Starbucks, Raley’s, restaurants, and...
Sprig Oral Health Technologies, Inc Loomis, CA, USA Full time
May 02, 2022  
Position Summary and Responsibilities: As a Software Engineer focused on our applications, you will report to Ceevra’s Chief Technology Officer. Your primary job focus will be on building the end-user client (desktop, mobile, and web) and back-end software that clinicians use, and on the automation frameworks for the validation of our machine learning models and other computer vision and graphics-related software. The responsibilities will extend to builds, deployments, data engineering, and the implementation of state-of-the-art machine learning models used to benchmark our software. Local candidates are preferred, although we’ll consider highly qualified remote candidates with at least two years of on-the-job experience. If local, we envision 3 days per week in our SF offices (or more if preferred by the candidate). Responsibilities Develop desktop, mobile, and web-based applications (front-end, back-end, and native apps) Work with the engineering team on...
Ceevra San Francisco, CA, USA Full time
May 02, 2022  
$90,000 - $125,000 yearly
Position Summary: As a Medical Device Software Quality Engineer, your primary job focus will be designing, implementing, and extending the medical device quality processes for Ceevra software that generates and displays 3D models of patient anatomy. Local candidates are preferred, although we’ll consider highly qualified remote candidates. If local, we envision 3 days/week in our SF offices (or more if preferred by the candidate). Responsibilities Drive quality-focused design and development of Ceevra software, including defining appropriate requirements, and creating and executing verification and validation plans and protocols Maintain and extend Ceevra’s Quality Management System Oversee various quality management activities, such as management reviews, internal audits, and external audits Develop quality practices applicable to cutting edge technologies with evolving regulatory guidelines such as Machine Learning Requirements At least three years...
Ceevra San Francisco, CA, USA Full time
May 02, 2022  
What and who we are:   UltraLinq is a SaaS cloud-based medical image solution. We give our clients the ability to read, store, report and archive medical images anytime and from anywhere with an internet connection. We are a mature SaaS company with a startup mentality. Our team solely consists of passionate, motivated problem-solvers dedicated to providing exemplary service to our customers as we improve the healthcare experience for healthcare providers and professionals. We nurture a casual, diverse, and energetic atmosphere with highly supportive co-workers. Who we need:   We are currently seeking a Regulatory and Quality Assurance Specialist to join our team in our New York, NY or Durham, NC office. This is a great position for someone who enjoys working as part of a small team and leading in the maintenance and expansion of regulatory processes. Why you should apply:   If you are looking to make a significant impact in the Quality and Regulatory Assurance space, this...
UltraLinq Healthcare Solutions Remote (Raleigh-Durham, Durham, NC, USA) Full time